Werbung
17 In the "Cleaning and Maintenance" chapter, in the "Preventive Maintenance" section, in the "Cleaning, Disinfecting, and
Inspecting the Accessories for Damage" subsection, edited the following warning:
WARNING: Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore pose a potential
risk to patients and personnel. Before each use, carefully inspect the accessories and packaging for damage. If you see
any sign of damage to any accessory, immediately discontinue use.
18 In the "Cleaning and Maintenance" chapter, in the "Preventive Maintenance" section, in the "Cleaning, Disinfecting, and
Inspecting the Accessories for Damage" subsection, added the following caution statement:
CAUTION: To prevent fluid ingress, do not subject the accessory to automated cleaning.
19 In the "Cleaning and Maintenance" chapter, in the "Preventive Maintenance" section, added the following subsection:
Accessory Cleaning and Disinfection
This section applies to all reusable
accessory before use and between patients.
•CAUTION: Do not submerge, soak or immerse the device in liquid, and do not allow liquid or soil to enter the device or
you may damage the device. Do not disconnect the accessory.
•CAUTION: Clean and disinfect
Otherwise, exposure to hazardous chemicals may cause a skin reaction, and improper disinfection may cause
infection.
Requirements:
• Enzymatic detergent cleaning solution
prepared according to the manufacturer's
instructions
• Deionized water
Procedure:
1. Inspect the accessory. If it is damaged or broken, discard it. Otherwise, go to the next step.
2. Do not disconnect the accessory from any other part of the system. Use a lint-free cloth dampened (not dripping)
with deionized water to remove excess soil.
3. Dampen another lint-free cloth with the prepared enzymatic cleaning solution.
4. Gently clean the accessory. Ensure you remove all visible soil.
5. Repeat steps 3 and 4, using a swab or brush to access crevices or small areas.
6. Use a clean, lint-free cloth or swab, dampened (not dripping) with deionized water to remove any excessive
detergent residue.
7. Inspect for cleanliness. Repeat steps 3 through 6 until the surfaces are visibly clean.
8. Allow to dry completely.
9. Use a lint-free cloth to wipe the alcohol onto the accessory, thoroughly wetting the surfaces.
10. Keep wet 12 minutes.
11. Allow to air dry.
12. Inspect the accessory. If liquid has entered the accessory, if it is damaged or broken, or if soil remains visible,
discard it.
20 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section,
added the following subsection:
Universal Gating Interface Cleaning and Disinfection
CAUTION: Do not submerge, soak or immerse the device in liquid or damage may occur to the device.
The Universal Gating Interface should be cleaned via the hospital's cleaning and disinfecting policies for MRI
housekeeping surfaces.
Expression Model MR200 MRI Patient Monitoring System, Instructions for Use Addendum
SpO
clips, ECG cables, and NBP cuffs and hoses. Clean and disinfect the
2
SpO
clips, ECG cables, and NBP cuffs and hoses according to this procedure.
2
• 70% isopropyl alcohol
• Lint-free cloths
• Soft-bristle brush or cotton swabs
5
Werbung
